510(k) K153769
K153769 is an FDA 510(k) premarket notification submitted by Lutronic Corporation for the device "R:GEN Laser System". The FDA issued a decision of Substantially Equivalent on October 5, 2016. The device falls under product code HQF (Laser, Ophthalmic), a Class II device regulated under 21 CFR 886.4390. Lutronic Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 5, 2016
- Date Received
- December 30, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laser, Ophthalmic
- Device Class
- Class II
- Regulation Number
- 886.4390
- Review Panel
- OP
- Submission Type